Kornimate/medical-research-clean huggingface dataset:
observational study of kibow biotics in dialysis patients

Conditions: Chronic Kidney Failure

Summary: a specifically formulated probiotic product comprised of defined and tested microbial strains may afford renoprotection in what has been generally called "enteric dialysistm". however, it is also referred to as enteric toxin reduction technology. our hypothesis is to assess the potential benefits in devising a bowel-based probiotic formulation (kibow® biotics/renadyltm) as a dietary supplement product for patients undergoing dialysis along with standardized care of treatment.

probiotics are increasingly utilized clinically. as their safety and health benefits are established, it is reasonable to anticipate that probiotic bacteria will be incorporated into a growing number of clinical regimens, as a dietary supplement. extensive in vitro r\&d investigations in kibow's laboratories bacterial strains studied were a mixture of patented and proprietary strains of streptococcus thermophilus (kb27), lactobacillus acidophilus (kb31) and bifidobacterium longum (kb35). oral administration of these bacterial formulations, tested in the 5/6th nephrectomized rat model (at thomas jefferson university, phila., pa) and minipig model (at indiana university, indianapolis, in), decreased both blood urea nitrogen (bun) and serum creatinine (scr) levels. two independent veterinarians investigated the effect of kibow biotics® in cats and dogs (of both genders and varying body weights) with moderate to severe kidney failure. based on positive results, this formulation, marketed and distributed as azodyltm, is currently licensed for veterinary applications to vetoquinol usa. pilot scale studies, double blind, placebo controlled, cross-over studies for six months conducted in 45 patients in usa, canada, argentina, and nigeria demonstrates reduction of bun (p\>95%) and improved quality of life (p\>95%). decrease in creatinine and uric acid levels were also observed. however, these studies were based on correlating the age of geriatric cats and dogs with moderate to significant kidney failure to human geriatric conditions. the proposed current study is being reevaluated based on correlating the weight basis of animal to human conditions. hence, this is a does escalation study on ingestion of 1x (90 billion cfu/day), 2x (180 billion cfu/day), and 3x (270 billion cfu/day) dosages.

Eligibility criteria:
inclusion criteria: * currently on hemodialysis * 18 to 75 years of age * willing to give informed consent * baseline serum creatinine \>2.5 mg/dl exclusion criteria: * pregnant or nursing women * refusal to sign the informed consent form * documented to have hiv/aids/liver disease * active dependency on drugs or alcohol * currently on anticoagulant therapy

Keywords: probiotics kibow biotics dialysis gut based uremic toxin removal
al to improve the diagnosis of rare rheumatic diseases

Conditions: Rheumatic Diseases

Summary: this trial aims to assess the impact of providing medical students with access to chatgpt, a state-of-the-art large language model, in comparison to conventional diagnostic decision support tools, on their diagnostic accuracy for rare rheumatic diseases.

advanced artificial intelligence (ai) technologies, particularly large language models such as openai's chatgpt, hold significant potential for enhancing medical decision-making. while chatgpt was not specifically designed for medical applications, it has shown utility in various healthcare scenarios, including answering patient inquiries, drafting medical documentation, and aiding consultations. despite these advancements, its role in supporting diagnostic reasoning-especially among less experienced medical students-and for complex rare diseases remains underexplored. diagnostic reasoning is a multifaceted process that combines pattern recognition, knowledge synthesis, and probabilistic thinking. tools like chatgpt could potentially alleviate cognitive burden, enhance diagnostic accuracy, and ultimately accelerate the diagnosis for rare diseases. however, chatgpt is not tailored for diagnostic reasoning and lacks comprehensive validation in this domain. additionally, it is susceptible to generating misinformation or plausible-sounding but inaccurate responses, which may hinder rather than support clinical decision-making. therefore, understanding how medical students utilize such ai tools is essential before they are integrated into educational or clinical workflows. this study will also assess a standardized prompt to facilitate chatgpt usage and will give students direct access to enable a realistic scenario. this study will investigate the impact of chatgpt on the diagnostic accuracy of medical students when tackling cases of rare rheumatic diseases. participants will be randomized into two groups: one with access to chatgpt and one using conventional diagnostic tools. each participant will analyze diagnostic cases by providing up to 5 differential diagnoses and and rating the diagnostic confidence. independent reviewers, blinded to group allocation, will evaluate the accuracy and quality of their responses. this study hence aims to provide insights into the potential benefits and limitations of integrating ai tools like chatgpt.

Eligibility criteria:
inclusion criteria: * medical students having started with clinical subjects (internal medicine) exclusion criteria: * not being a medical student

Keywords: large language models diagnostic decision support clinical reasoning rheumatology
sorafenib as adjuvant treatment in the prevention of recurrence of hepatocellular carcinoma (storm)

Conditions: Carcinoma, Hepatocellular

Summary: to evaluate efficacy and safety of sorafenib versus placebo in the adjuvant treatment of hepatocellular carcinoma (hcc) after potentially curative treatment (surgical resection or local ablation).


Eligibility criteria:
inclusion criteria: * subjects who have undergone surgical resection or local ablation (pei or percutaneous or intraoperative rfa) for treatment of hcc with curative intent within 4 months from staging to potentially curative treatment. a maximum of 2 local ablation courses may be administered during this time period. * at least 3 weeks (21 days) but no more than 7 weeks (49 days), from resection or last local ablation course, to ct/mri scan date * male or female subjects \>/= 18 years of age * confirmation of cr (absence of residual tumor after curative treatment), on the eligibility scan by independent radiological review. * for subjects undergoing surgical resection pathology proven complete removal of tumor. * intermediate or high risk of recurrence as assessed by tumor characteristics. * child-pugh score 5 -7 points. a child-pugh score of 7 points is allowed only in the absence of ascites. * ecog performance status of 0. * adequate bone marrow, liver and renal function exclusion criteria: * recurrent hcc * child-pugh score 7 points with presence of ascites. * low risk of recurrence after curative treatment * history of cardiovascular disease * history of hiv infection * active clinically serious infections (\> grade 2 nci-ctcae version 3.0) * subjects with seizure disorder requiring medication (such as steroids or anti-epileptics) * subjects with evidence or history of bleeding diathesis * subjects undergoing renal dialysis * previous or concurrent cancer that is distinct in primary site or histology from the cancer being evaluated in this study except cervical carcinoma in situ, treated basal cell carcinoma, superficial bladder tumors \[ta, tis \& t1\] or any cancer curatively treated \> 3 years prior to study entry as defined by the signing of informed consent.. * uncontrolled ascites (defined as not easily controlled with diuretic treatment) * encephalopathy * history of gi bleeding within 30 days of randomization. * subjects with a history of esophageal varices bleeding which has not been followed by effective therapy and/or treatment to prevent bleeding recurrence. * prior anti cancer therapy for treatment of hcc (including sorafenib or any other molecular therapy) is excluded. * major surgery within 4 weeks of start of study as defined by the signing of informed consent, except for surgical resection or local ablation of hcc. * investigational drug therapy outside of this trial during or within 4 weeks of study entry, as defined by the signing of informed consent. * liver transplantation, this includes patients on a transplant list with the intention to transplant

Keywords: hepatocellular carcinoma sorafenib adjuvant surgical resection ablation nexavar adjuvant therapy liver cancer hcc storm
clinical study on the prevention of surgical wound complications for aneurysmal thoracic-abdominal aortic pathology using the "prevena" system

Conditions: Toraco Abdominal Aneurysm

Summary: the patients will be randomized into two groups of 100 subjects each one. one arm will be randomized to treatment with a negative topical pressure system (sistema prevena ™); while the other arm ("control group") will be randomized to treatment with standard medication with sterile gauzes and a tnt patch or medicated patch as normal traditional medication in use. the medications with a negative topical pressure system (sistema prevena ™) will be applied directly in the operating room. thereafter the medication will be checked in the inpatient ward after 48 hours from the intervention, evaluating the possible absorption of exudate on the surface. if no absorption are detected within 48 hours, the medication won't be removed. the medication will be renewed in the 7th day (± 2 days) post-operative; and to follow every 7 (± 2 days) until the points are removed. if the wound continues to progress towards recovery, the protocol will continue until discharge and / or rehabilitation and / or surgery. for each evaluation the photograph of the medication must be taken (which will be deprived of all the identifying elements of the patient).


Eligibility criteria:
inclusion criteria: * patients over 18 years; * patients of any sex, race, age, who have accepted to participate in the study by signing the informed consent form of the study. * patients with surgical wounds to treat thoracic-abdominal aortic pathology. exclusion criteria: * patients with established sepsis; * patients with septic recurrence; * patients with sensitivity to silver.

Keywords: surgical wound prevena system
imatinib versus imatinib and peg-interferon in patients with ph+ cml and complete cytogenetic response after imatinib therapy

Conditions: Leukemia, Myeloid, Philadelphia-Positive

Summary: the study is controlled and randomized in philadelphia-positive chronic myeloid leukemia (ph+ cml) patients with complete cytogenetic response after more than one year of imatinib therapy. the aim is to explore a possible benefit in the addition of peg-interferon (peg-ifn) to imatinib, in terms of the rate of achievement, molecular remission, and response duration.


Eligibility criteria:
inclusion criteria: * ph+ cml patients in complete cytogenetic response (ccr) after more than 1 year of imatinib therapy. exclusion criteria: * patients in imatinib study * patients with a history of intolerability to interferon. * patients with less than ccr or less than one year of imatinib therapy.

Keywords: cml imatinib pegylated interferon philadelphia positive cml
an investigational agent for the treatment of complicated intra-abdominal infections or acute pelvic infections (0826-038)

Conditions: Infections; Pelvic Infections

Summary: the purpose of this study is to determine the effect of an approved medication for adults for an investigational use in pediatric patients 3 months to 17 years for the treatment of complicated intra-abdominal infections or acute pelvic infections.

the duration of treatment is 18 months.

Eligibility criteria:
inclusion criteria: * patients aged 3 months to 17 years with intra-abdominal infection or acute pelvic infection exclusion criteria: * immune problems * kidney problems

Keywords: intra-abdominal infections acute pelvic infections
anastomotic leakage after anterior resection of rectal cancer

Conditions: Rectal Cancer

Summary: anastomotic leakage (al) is one of the most-feared postoperative complications after anterior resection of rectal cancer. this complication compromises both short term and long term outcome of patients. the incidence of al after anterior resection was approximately 6-11%. although several risk factors for al such as male sex, smoking, tumor location, longer operative time, intraoperative blood loss had been reported in previous studies, the incidence of al did not meet a significant decrease. so far there is no multi-site observational study on incidence and risk factors of al after anterior resection in china, therefore this study aims to work on this issue and provide evidence for clinical practice.


Eligibility criteria:
inclusion criteria: * adenocarcinoma of the rectum by biopsy * single lesion * anterior resection was performed * anastomosis using circular stapler exclusion criteria: * history of colorectal cancer surgery * emergency surgery because of bowel obstruction, bleeding or perforation * colo-anal anastomosis * subtotal colectomy * total colectomy * abdominal perineal resection * hartmann procedure * pull out anastomosis

Keywords: anastomotic leakage anterior resection risk factors incidence rectal cancer
zinc supplementation prior to botox injections for spasmodic dysphonia

Conditions: Spasmodic Dysphonia

Summary: one initial study has shown that botulinum toxin (bt) in combination with zinc supplementation may increase the duration of effects bt treatment. this initial study was in the context of facial aesthetics. the purpose of the present study is to determine the effect, if any, of oral zinc supplementation prior to bt in the treatment of spasmodic dysphonia. if positive effects will be observed, this would help reduce the burden of disease for these patients.

botulinum toxin (bt) injections are commonly used to treat various cosmetic, muscular, anesthetic, and neurologic pathologies. in 2012, one study suggested that a combination of zinc and phytase supplementation could increase the duration and degree of effects of botulinum neurotoxin type a (bonta). however, this study was met with scientific skepticism due to concerns of financial conflicts of interest, unmasking the study too early, and ambiguity of the dosage of zinc used. in 2021, a new study with 25 patients receiving bonta injections for the treatment of excessive gingival display (egd), showed that zinc supplementation prolonged the effect of bonta with statistical significance. there has been no further studies or commentary since these latest results were published. the purpose of this study is to test if the effect of zinc supplementation on bonta can be replicated and also translated to a different disease process that is also treated with bt-spasmodic dysphonia (sd). if positive effects are discovered, this would strengthen the preliminary results of the 2021 study, encourage future larger studies on the same hypothesis, and, ultimately, could lead to reducing the burden of disease for patients with sd and any other condition that is treated with bt injections.

Eligibility criteria:
inclusion criteria: * adults patients * 18 years old and above * current diagnosis of adductor spasmodic dysphonia * has had botox injection treatments for sd \> 6 months exclusion criteria: * pregnant * diagnosis of abductor spasmodic dysphonia * patients taking \> 30 mg zinc supplementation daily prior to study beginning

Keywords: zinc botox botulinum toxin spasmodic dysphonia
phase 3 extension study of the safety and efficacy of aldurazyme® (laronidase) in mucopolysaccharidosis i (mps i) patients

Conditions: Mucopolysaccharidosis I; Hurler's Syndrome; Hurler-Scheie Syndrome; Scheie Syndrome

Summary: this study is being conducted to collect additional long-term efficacy and safety data of aldurazyme® (laronidase) patients with mps i disease. patients who were previously enrolled in the phase 3 double-blind study will be enrolled in this study.


Eligibility criteria:
inclusion criteria: * the patient or patient's legal guardian must provide written informed consent prior to any protocol-related procedures being performed. * the patient must have successfully completed study alid-003-99 (who received 21 of 26 consecutive weekly infusions). * the patient has not experienced any safety issues that would contraindicate participation in the extension study. * a female patient of childbearing potential must have a negative pregnancy test at entry exclusion criteria: * the patient is pregnant or lactating. * the patient has received an investigational drug within 30 days prior to the study enrollment. * the patient has a medical condition, serious intercurrent illness, or other extenuating circumstance that may significantly interfere with study compliance including all prescribed evaluations and follow-up activities
retrospective study to determine effect of rebif and tecfidera on infections and lymphocytes

Conditions: Relapsing-Remitting Multiple Sclerosis

Summary: this study will be a single center, retrospective, pilot study to determine the effect of rebif (interferon beta-1a) and tecfidera (dimethyl fumarate) on infections on total lymphocyte counts, grade of lymphopenia, cluster of differentiation 4 (cd4) and cluster of differentiation 8 (cd8) counts and ratios in subjects aged 50 years and above with relapsing-remitting multiple sclerosis (rrms).


Eligibility criteria:
inclusion criteria: * rrms subjects who have been treated with interferon beta 1a sc 44 micro-gram thrice a week and dimethyl fumarate in inpatient or outpatient settings during the period from january 1, 2015 to december 31, 2015. * subjects with at least one year of laboratory values post-index date to analyze lymphocyte counts, and cd4 and cd8 counts. the date of first blood draw for laboratory tests after january 1, 2015 will be defined as the subject's index date. exclusion criteria: - subjects who have been on treatment for less than 1 year after their index date.

Keywords: interferon beta-1a dimethyl fumarate rebif tecfidera relapsing-remitting multiple sclerosis
intravitreal bevacizumab vs. bevacizumab combined with triamcinolone for neovascular amd

Conditions: Neovascular Age-Related Macular Degeneration

Summary: to compare the efficacy and safety results of intravitreal bevacizumab alone with bevacizumab + triamcinolone acetonide in neovascular amd.


Eligibility criteria:
inclusion criteria: * cases of active neovascular amd with visual acuity of 20/400- 20/40 exclusion criteria: * history of glaucoma or ocular hypertension * disciform scar

Keywords: bevacizumab, triamcinolone age-related macular degeneration choroidal neovascular membrane
a double-blind study of e5555 in japanese subjects with coronary artery disease

Conditions: Coronary Artery Disease

Summary: the purpose of this study is to assess the safety and tolerability of e5555 in japanese subjects with coronary artery disease.


Eligibility criteria:
inclusion criteria: 1. 45 - 80 years old (at time of informed consent). 2. male or female (females of childbearing potential must use contraception). 3. confirmed coronary artery disease. 4. all subjects must be receiving aspirin (75 - 325 mg). exclusion criteria: 1. unwilling or unable to provide informed consent. 2. history of acquired or congenital bleeding disorder, coagulopathy, or platelet disorder. 3. recent trauma or major surgery. 4. evidence of active pathological bleeding or history of bleeding such as gastrointestinal or genitourinary, unless the cause has been definitely corrected. 5. history of intracranial bleeding or history of hemorrhagic retinopathy. 6. new york heart association class iii or iv congestive heart failure. 7. pregnant or lactating women.

Keywords: coronary artery disease
the efficacy of combined intrathecal morphine and peng block on postoperative pain in hip arthroplasty

Conditions: Postoperative Pain Management

Summary: this study aims to compare the postoperative 48-hour period in terms of morphine consumption, postoperative pain, and quality of recovery scores by combining the pericapsular nerve group (peng) block with low-dose intrathecal morphine in hip arthroplasty, as opposed to peng alone and intrathecal morphine alone.

effective postoperative pain control in hip surgeries can reduce complications and improve postoperative care. multimodal analgesic techniques in postoperative pain management are employed to synergistically target different nociceptive mechanisms. combining peripheral nerve blocks with low-dose intrathecal opioids can decrease the systemic opioid dose. additionally, side effects associated with opioids, such as sedation, respiratory depression, nausea, vomiting, rash, and urinary retention, can be mitigated by the combination with peripheral nerve blocks. the addition of pericapsular nerve group (peng) block to a multimodal analgesia regimen has been shown to significantly enhance the quality of recovery and reduce opioid consumption in patients undergoing hip arthroplasty. the quality of recovery (qor-15), developed and validated by stark et al. in 2013, is a recovery scale indicating postoperative recovery quality. it includes 15 questions assessing pain, physical comfort, physical independence, psychological support, and emotional state, providing a score between 0 and 150, where a higher score indicates better recovery quality. in anterior hip surgeries, it is anticipated that spinal anesthesia combined with peng block and low-dose intrathecal morphine will result in lower postoperative morphine consumption and pain scores compared to peng alone and intrathecal morphine alone over the first 48 hours. furthermore, it is expected that the quality of recovery (qor-15 score) will be higher, providing patients with a longer pain-free period, early mobilization, and improved recovery quality.

Eligibility criteria:
inclusion criteria: * aged between 18 and 90 years * american society of anesthesiologists (score ranging from 1 to 4) * anterior hip arthroplasties exclusion criteria: * patients with a history of opioid addiction * individuals under the age of 18 * those aged 90 and above * allergies to morphine, fentanyl, bupivacaine, or tramadol * coagulopathy * infection at the injection site * severe cardiac, renal, or hepatic dysfunction * cases unable to provide informed consent * body mass index \>40 kg/m2 * known neurological or anatomical deficits in the lower extremities * patients requiring a transition from spinal anesthesia to general anesthesia

Keywords: postoperative pain intrathecal morphine intrathecal bupivacaine hip arthroplasty pericapsular nerve group block